KidCap
Orthosis, Cranial
Eastern Cranial Affiliates, LLC
The following data is part of a premarket notification filed by Eastern Cranial Affiliates, Llc with the FDA for Kidcap.
Pre-market Notification Details
| Device ID | K180568 |
| 510k Number | K180568 |
| Device Name: | KidCap |
| Classification | Orthosis, Cranial |
| Applicant | Eastern Cranial Affiliates, LLC 10523 Main Street Fairfax, VA 22030 |
| Contact | Joseph Terpenning |
| Correspondent | Joseph Terpenning Eastern Cranial Affiliates, LLC 10523 Main Street Fairfax, VA 22030 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-10-16 |
| Summary: | summary |
Trademark Results [KidCap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KIDCAP 79034848 3405710 Dead/Cancelled |
Special Products Limited 2006-12-27 |
 KIDCAP 77389171 not registered Dead/Abandoned |
Rekstad, Stephen S. 2008-02-05 |
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